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CompletedNCT00908674Updated Apr 13, 2010

Androcur Effects on Quality of Life

An observational study in Prostate Cancer, sponsored by Bayer. Completed at 1 site in Hungary. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-13.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
245
Ages
18 Years and older
Sex
Male
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Study summary

Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is used for treatment of advanced prostate cancer. This study investigates the effect of Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months

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Conditions studied

  • Prostate Cancer

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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 245 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with advanced prostate cancer

Inclusion criteria

  • Histologically confirmed adenocarcinoma of the prostate
  • Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
  • Locally advanced tumor or distant metastases is present

Exclusion criteria

Exclusion Criteria:

  • Patient not fulfil the recruitment criteria
  • Liver disease; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases); wasting diseases (with the exception of carcinoma of the prostate); depression; previous or existing thromboembolic processes; diabetes with vascular changes; sickle-cell anaemia.
  • As regards patients with prostatic carcinoma who have a history of thromboembolic processes and/or an existing sickle-cell anaemia, or diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual case before the use of Androcur
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
245 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Cyproterone acetate (Androcur)

Interventions

  • DrugCyproterone acetate (Androcur)

    The study drug will be administered either as monotherapy or in combination with other interventions (surgical castration or LHRH analogue treatment). Daily dosage as monotherapy: 200-300 mg cyproterone acetate. Daily dosage following surgical castration: 100-200 mg cyproterone acetate. Daily dosage in combination with an LHRH-analogue: 100-200 mg cyproterone acetate. Administration period: 12 months.

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What researchers measure

Primary outcomes

  1. Quality of life change measured by SF-35 questionnaire

    Time frame: Baseline, after 3, 6 and 12 month

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Study locations

1 site
  • Many Locations, Hungary
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00908674
Lead sponsor
Bayer
First posted
May 27, 2009
Start date
Jun 2008
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Apr 13, 2010

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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